APPLICATION
ANDA091426
TYPE
ANDA
ORIGINAL APPROVAL
2010-07-02
LATEST ACTION
2023-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SPIRONOLACTONEPrescription
SPIRONOLACTONE 100MG · TABLET · ORAL
SPIRONOLACTONEPrescription
SPIRONOLACTONE 25MG · TABLET · ORAL
SPIRONOLACTONEPrescription
SPIRONOLACTONE 50MG · TABLET · ORAL
Approval history
2023-06-28Labeling · Supplement 26 · standardAP
2021-02-22Labeling · Supplement 17 · standardAP
2019-08-05Labeling · Supplement 9 · standardAP
2015-12-02Labeling · Supplement 6 · standardAP
2015-12-02Labeling · Supplement 4 · standardAP
2015-12-02Labeling · Supplement 7 · standardAP
2015-12-02Manufacturing (CMC) · Supplement 5 · unknownAP
2015-12-02Labeling · Supplement 3 · standardAP
2011-11-28Labeling · Supplement 2AP
2010-07-02OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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